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Completed

NCT Number: NCT01799512

Glucose Control in the ICU Using Continuous Glucose Monitoring

Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia.

This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Middelheim General Hospital, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted to a medical intensive care unit
  • age: ≥ 18 y , < 75 y
  • APACHE II (Acute Physiology and Chronic Health Evaluation II) score ≥ 20
  • expected length of stay in ICU > 3 days

Exclusion criteria

  • pregnancy
  • patient with a DNR (do not reanimate) code
  • surgical patient
  • no informed consent

Treatment and study plan

experimental: real-time continuous glucose monitoring

Device

Other names: RT-CGM using the GlucoDay device (A. Menarini, Italy)

Active comparator: blinded continuous glucose monitoring

Device

Primary outcomes

  1. percentage of time that patients are in target range of glycaemia (80-110 mg/dl)

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU

Secondary outcomes

  1. percentage of time that patients are in hypoglycaemic range

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU

Other outcomes

  1. accuracy of continuous glucose monitoring

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period

  2. glycaemic fluctuations

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period

  3. accuracy of continuous glucose monitoring

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    Bland-Altman bias plot will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period

  4. accuracy of continuous glucose monitoring

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    mean absolute error and mean relative error will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period

  5. glycaemic fluctuations

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    MAGE (mean amplitude of glucose excursions), analysing all data of the 4 days of continuous glucose monitoring period

  6. glycaemic fluctuations

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    CONGA (continuous overlapping net glycemic action), analysing all data of the 4 days of continuous glucose monitoring period

  7. glycaemic fluctuations

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    area under curve (within target glycemia range, above target, below target) analysing all data of the 4 days of continuous glucose monitoring period

  8. glycaemic fluctuations

    Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

    MODD: mean of daily differences; analysing all data of the 4 days of continuous glucose monitoring period

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)

Acronym: REGIMEN

Important dates

Study start
2007
Primary completion
2010
Study completion
2013
First posted
Feb 26, 2013
Registry last updated
Feb 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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